Pub Date : 2025-01-01DOI: 10.2500/aap.2025.46.240099
Jonathan M Gabbay, Michael D Fishman, Benjamin V M Bajaj, Cara S Guenther, Robert J Graham, Jennifer M Perez
Objective: To evaluate the association of parenteral epinephrine and terbutaline use on ventilatory support in children admitted to the intensive care unit (ICU) with critical asthma in the United States. Methods: Data were obtained from the Pediatric Health Information System data base for children ages 2 to 18 years admitted to the ICU with a diagnosis of asthma exacerbation from January 1, 2016, to December 31, 2023. The primary outcomes included noninvasive ventilation (NIV) and/or invasive mechanical ventilation (IMV) use after receipt of terbutaline and/or epinephrine. Secondary outcomes included serious adverse events from parenteral bronchodilators, including arrhythmias and elevated troponins. Results: Our study population included 53,328 patient encounters. Terbutaline and epinephrine were associated with decreased odds of subsequent NIV (terbutaline: odds ratio [OR] 0.52 [95% confidence interval {CI}, 0.44-0.63], p < 0.001; and epinephrine: OR 0.49 [95% CI, 0.43-0.55], p < 0.001) and subsequent IMV (terbutaline: OR 0.51 [95% CI, 0.42-0.61], p < 0.001; and epinephrine: OR 0.34 [95% CI, 0.29-0.41], p < 0.001). There were no differences in adverse events in the terbutaline group when compared with the epinephrine group for both arrhythmia and elevated troponins (arrhythmia: terbutaline = 1.9%, epinephrine = 1.7%; p = 0.6; and elevated troponins: terbutaline = 0.1%, epinephrine = 0.1%, p > 0.9). Conclusion: Parenteral bronchodilator use was associated with decreased odds of receiving subsequent ventilatory support in critical asthma. There were low rates of arrhythmia and elevated troponin overall. Our findings should inform future clinical trials to evaluate the use of parenteral bronchodilators in critical asthma in the United States.
{"title":"Efficacy of parenteral bronchodilators on ventilatory outcomes in pediatric critical asthma: a national cohort study.","authors":"Jonathan M Gabbay, Michael D Fishman, Benjamin V M Bajaj, Cara S Guenther, Robert J Graham, Jennifer M Perez","doi":"10.2500/aap.2025.46.240099","DOIUrl":"10.2500/aap.2025.46.240099","url":null,"abstract":"<p><p><b>Objective:</b> To evaluate the association of parenteral epinephrine and terbutaline use on ventilatory support in children admitted to the intensive care unit (ICU) with critical asthma in the United States. <b>Methods:</b> Data were obtained from the Pediatric Health Information System data base for children ages 2 to 18 years admitted to the ICU with a diagnosis of asthma exacerbation from January 1, 2016, to December 31, 2023. The primary outcomes included noninvasive ventilation (NIV) and/or invasive mechanical ventilation (IMV) use after receipt of terbutaline and/or epinephrine. Secondary outcomes included serious adverse events from parenteral bronchodilators, including arrhythmias and elevated troponins. <b>Results:</b> Our study population included 53,328 patient encounters. Terbutaline and epinephrine were associated with decreased odds of subsequent NIV (terbutaline: odds ratio [OR] 0.52 [95% confidence interval {CI}, 0.44-0.63], p < 0.001; and epinephrine: OR 0.49 [95% CI, 0.43-0.55], p < 0.001) and subsequent IMV (terbutaline: OR 0.51 [95% CI, 0.42-0.61], p < 0.001; and epinephrine: OR 0.34 [95% CI, 0.29-0.41], p < 0.001). There were no differences in adverse events in the terbutaline group when compared with the epinephrine group for both arrhythmia and elevated troponins (arrhythmia: terbutaline = 1.9%, epinephrine = 1.7%; p = 0.6; and elevated troponins: terbutaline = 0.1%, epinephrine = 0.1%, p > 0.9). <b>Conclusion:</b> Parenteral bronchodilator use was associated with decreased odds of receiving subsequent ventilatory support in critical asthma. There were low rates of arrhythmia and elevated troponin overall. Our findings should inform future clinical trials to evaluate the use of parenteral bronchodilators in critical asthma in the United States.</p>","PeriodicalId":7646,"journal":{"name":"Allergy and asthma proceedings","volume":"46 1","pages":"e6-e12"},"PeriodicalIF":2.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142908840","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: Cutaneous mastocytosis (CM) is the most common type of mastocytosis in children. The atopy frequency in these patients is typically similar to that in the general population, but a higher incidence of anaphylaxis is reported. Objective: This study aimed to evaluate the presence of allergic diseases in children diagnosed with CM and its impact on clinical manifestations. Methods: Children diagnosed with CM at Ankara Bilkent City Hospital Pediatric Allergy and Immunology Clinic between September 2019 and September 2023 were included in the study. Data, including demographic information, clinical details, and laboratory results, were gathered from medical records, encompassing personal and family allergy history. Results: The study included 58 patients (median [interquartile range{IQR}] age, 64 months [29-100.5 months]; 69% boys) with skin lesions as the primary concern. The median (IQR) age at which the lesions appeared was 9 months (3-39.25 months), and the median (IQR) age at hospital admission was 12 months (5- 50 months). The median (IQR) age at CM diagnosis was 13 months (6-53.5 months). The median (IQR) baseline tryptase value was 5.45 μg/L (3.93-9.00 μg/L), and 16 had an elevated tryptase value (>8 μg/L). Allergic diseases were present in 39.65% of the patients, with atopic dermatitis (18.9%) being the most common, followed by asthma (10.3%), allergic rhinitis (5.2%), food allergy (1.7%), and drug and bee venom allergies (1.7%). One patient had a history of anaphylaxis, diagnosed 4 months after consuming yogurt. A total of 18 patients, including this patient, were prescribed an adrenaline autoinjector. Conclusion: Various allergic diseases occurred in ∼40% of patients with CM and most commonly manifest as atopic dermatitis; 31% patients with risk factors for anaphylaxis were prescribed an adrenaline autoinjector.
{"title":"Evaluation of allergic diseases in children diagnosed with cutaneous mastocytosis.","authors":"Hatice Irmak Celik, Funda Aytekin Guvenir, Zeynep Sengul Emeksiz, Emine Dibek Misirlioglu","doi":"10.2500/aap.2025.46.240093","DOIUrl":"10.2500/aap.2025.46.240093","url":null,"abstract":"<p><p><b>Background:</b> Cutaneous mastocytosis (CM) is the most common type of mastocytosis in children. The atopy frequency in these patients is typically similar to that in the general population, but a higher incidence of anaphylaxis is reported. <b>Objective:</b> This study aimed to evaluate the presence of allergic diseases in children diagnosed with CM and its impact on clinical manifestations. <b>Methods:</b> Children diagnosed with CM at Ankara Bilkent City Hospital Pediatric Allergy and Immunology Clinic between September 2019 and September 2023 were included in the study. Data, including demographic information, clinical details, and laboratory results, were gathered from medical records, encompassing personal and family allergy history. <b>Results:</b> The study included 58 patients (median [interquartile range{IQR}] age, 64 months [29-100.5 months]; 69% boys) with skin lesions as the primary concern. The median (IQR) age at which the lesions appeared was 9 months (3-39.25 months), and the median (IQR) age at hospital admission was 12 months (5- 50 months). The median (IQR) age at CM diagnosis was 13 months (6-53.5 months). The median (IQR) baseline tryptase value was 5.45 μg/L (3.93-9.00 μg/L), and 16 had an elevated tryptase value (>8 μg/L). Allergic diseases were present in 39.65% of the patients, with atopic dermatitis (18.9%) being the most common, followed by asthma (10.3%), allergic rhinitis (5.2%), food allergy (1.7%), and drug and bee venom allergies (1.7%). One patient had a history of anaphylaxis, diagnosed 4 months after consuming yogurt. A total of 18 patients, including this patient, were prescribed an adrenaline autoinjector. <b>Conclusion:</b> Various allergic diseases occurred in ∼40% of patients with CM and most commonly manifest as atopic dermatitis; 31% patients with risk factors for anaphylaxis were prescribed an adrenaline autoinjector.</p>","PeriodicalId":7646,"journal":{"name":"Allergy and asthma proceedings","volume":"46 1","pages":"e1-e5"},"PeriodicalIF":2.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142908854","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01DOI: 10.2500/aap.2025.46.240076
Meghan V Matheny, Timothy Craig, Taha Al-Shaikhly
Background: Patients with mast cell activation syndrome (MCAS) can be refractory to standard antimediator therapy. Alternative treatment options to reduce disease burden and improve quality of life are needed. Objective: To compile the evidence that supports the use of omalizumab for patients with refractory MCAS. Methods: Through a systematic review of the PubMed database, we compiled and analyzed the characteristics of patients with refractory MCAS, unresponsive to histamine 1 receptor antihistamines plus another antimediator agent (refractory MCAS), and who were treated with omalizumab. We categorized the clinical response to omalizumab as no, partial, or complete response. Results: We identified nine studies that described a total of 28 patients (median age, 48 years; males, 54%) with refractory MCAS. Twenty-one patients (75%) had nonclonal MCAS, and seven patients (25%) had clonal MCAS. The omalizumab dose ranged from 150 mg every 4 weeks to 300 mg every 3 weeks, with the most common dose being 150 mg every 2 weeks. Most patients had a partial response (61%), and five patients achieved a complete response. Omalizumab was successful in ameliorating anaphylaxis and allowed for discontinuation of systemic glucocorticoids in two of three patients. The response pattern was not influenced by sex or mast cell clonality, but a complete response was reported more commonly among receivers of a higher omalizumab dose (≥300 mg/month). No major adverse events were reported. Conclusion: The majority of patients with refractory MCAS reported in the literature had a reduction in mast cell mediator-related symptoms with the addition of omalizumab.
{"title":"Systematic review of omalizumab for refractory clonal and non-clonal mast cell activation syndrome.","authors":"Meghan V Matheny, Timothy Craig, Taha Al-Shaikhly","doi":"10.2500/aap.2025.46.240076","DOIUrl":"10.2500/aap.2025.46.240076","url":null,"abstract":"<p><p><b>Background:</b> Patients with mast cell activation syndrome (MCAS) can be refractory to standard antimediator therapy. Alternative treatment options to reduce disease burden and improve quality of life are needed. <b>Objective:</b> To compile the evidence that supports the use of omalizumab for patients with refractory MCAS. <b>Methods:</b> Through a systematic review of the PubMed database, we compiled and analyzed the characteristics of patients with refractory MCAS, unresponsive to histamine 1 receptor antihistamines plus another antimediator agent (refractory MCAS), and who were treated with omalizumab. We categorized the clinical response to omalizumab as no, partial, or complete response. <b>Results:</b> We identified nine studies that described a total of 28 patients (median age, 48 years; males, 54%) with refractory MCAS. Twenty-one patients (75%) had nonclonal MCAS, and seven patients (25%) had clonal MCAS. The omalizumab dose ranged from 150 mg every 4 weeks to 300 mg every 3 weeks, with the most common dose being 150 mg every 2 weeks. Most patients had a partial response (61%), and five patients achieved a complete response. Omalizumab was successful in ameliorating anaphylaxis and allowed for discontinuation of systemic glucocorticoids in two of three patients. The response pattern was not influenced by sex or mast cell clonality, but a complete response was reported more commonly among receivers of a higher omalizumab dose (≥300 mg/month). No major adverse events were reported. <b>Conclusion:</b> The majority of patients with refractory MCAS reported in the literature had a reduction in mast cell mediator-related symptoms with the addition of omalizumab.</p>","PeriodicalId":7646,"journal":{"name":"Allergy and asthma proceedings","volume":"46 1","pages":"11-18"},"PeriodicalIF":2.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142908993","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01DOI: 10.2500/aap.2025.46.240102
Joseph A Bellanti, Russell A Settipane
{"title":"Exploring mast cell disorders: Tryptases, hereditary alpha-tryptasemia, and MCAS treatment approaches.","authors":"Joseph A Bellanti, Russell A Settipane","doi":"10.2500/aap.2025.46.240102","DOIUrl":"10.2500/aap.2025.46.240102","url":null,"abstract":"","PeriodicalId":7646,"journal":{"name":"Allergy and asthma proceedings","volume":"46 1","pages":"1-3"},"PeriodicalIF":2.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11694312/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142908788","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: Standardized quality (SQ) house-dust mite (HDM) sublingual immunotherapy tablets (10,000 Japanese allergy units [JAU], equivalent to 6 SQ-HDM in Europe and the United States) are licensed for the treatment of HDMinduced allergic rhinitis (AR) without age restriction, based on 52-week administration clinical trials. There are no large-scale data on the administration of 10,000 JAU for > 1 year in actual clinical practice.
Objective: To examine the safety and effectiveness of 10,000 JAU during use for up to 3 years at real-world clinical sites in Japan.
Methods: This survey was a multicenter, observational, prospective study. We assessed the safety and effectiveness of the long-term administration of 10,000 JAU as well as effectiveness after its discontinuation in patients with HDM AR with an observation period of 3 years.
Results: The safety analysis included 815 patients, and the effectiveness analysis included 768 patients. Adverse reactionsthat occurred in 144 patients (17.67%) were mainly site-related events that occurred early in the dosing period. Seriousadverse reactions were dyspnea and anaphylactic reaction in one patient each, and both patients recovered. With regard toeffectiveness, compared with scores before the administration of SQ-HDM, nasal symptom scores decreased, depending on theadministration period, from 6 months to 3 years. Overall, 67.34% of the patients had improved quality of life after 6 months, and this improvement continued after 12 months. The proportion of patients with "improved and slightly improved" of overallimprovement exceeded 90% after 2 years. Treatment discontinuation because "symptoms disappeared" occurred in 24.42% of the patients at 3 years. Patients who discontinued 10,000 JAU (n = 39) had a sustained improvement in nasal symptomscores compared with baseline, even 1 year after discontinuing treatment.
Conclusion: The real-world safety and effectiveness of 10,000 JAU SQ-HDM sublingual immunotherapy tablets were confirmed in Japanese patients with HDM AR. No new safety and effectiveness precautions were required.
背景:根据为期52周的临床试验,标准质量(SQ)的屋尘螨(HDM)舌下免疫疗法片剂(10,000日本过敏单位[JAU],在欧洲和美国相当于6 SQ-HDM)被许可用于治疗HDM引起的过敏性鼻炎(AR),没有年龄限制。目前还没有关于在实际临床实践中使用 10,000 JAU > 1 年的大规模数据:目的:在日本的临床实践中,研究 10,000 JAU 使用长达 3 年的安全性和有效性:这项调查是一项多中心、观察性、前瞻性研究。我们评估了长期服用 10,000 JAU 的安全性和有效性,以及在观察期为 3 年的 HDM AR 患者中停用 10,000 JAU 后的有效性:安全性分析包括 815 例患者,有效性分析包括 768 例患者。144名患者(17.67%)出现的不良反应主要是用药初期发生的与用药部位有关的事件。严重的不良反应是呼吸困难和过敏性反应,各有一名患者发生,两名患者均已痊愈。在疗效方面,与使用 SQ-HDM 前的评分相比,鼻部症状评分有所下降,具体取决于用药时间,从 6 个月到 3 年不等。总体而言,67.34% 的患者在 6 个月后生活质量有所改善,这种改善在 12 个月后仍在继续。2 年后,总体改善程度为 "改善和略有改善 "的患者比例超过 90%。3 年后,因 "症状消失 "而中断治疗的患者占 24.42%。停用 10,000 JAU 的患者(n = 39)的鼻腔症状评分与基线相比有持续改善,甚至在停药 1 年后也是如此:结论:10,000 JAU SQ-HDM 舌下免疫疗法片剂在日本 HDM AR 患者中的实际安全性和有效性得到了证实。无需采取新的安全性和有效性预防措施。
{"title":"Real-world surveillance of standardized quality (SQ) house dust mite sublingual immunotherapy tablets for 3 years in Japan.","authors":"Minoru Gotoh, Yuriko Maekawa, Shiori Saito, Noboru Kato, Eiji Horikawa, Noriaki Nishino","doi":"10.2500/aap.2024.45.240092","DOIUrl":"10.2500/aap.2024.45.240092","url":null,"abstract":"<p><strong>Background: </strong>Standardized quality (SQ) house-dust mite (HDM) sublingual immunotherapy tablets (10,000 Japanese allergy units [JAU], equivalent to 6 SQ-HDM in Europe and the United States) are licensed for the treatment of HDMinduced allergic rhinitis (AR) without age restriction, based on 52-week administration clinical trials. There are no large-scale data on the administration of 10,000 JAU for > 1 year in actual clinical practice.</p><p><strong>Objective: </strong>To examine the safety and effectiveness of 10,000 JAU during use for up to 3 years at real-world clinical sites in Japan.</p><p><strong>Methods: </strong>This survey was a multicenter, observational, prospective study. We assessed the safety and effectiveness of the long-term administration of 10,000 JAU as well as effectiveness after its discontinuation in patients with HDM AR with an observation period of 3 years.</p><p><strong>Results: </strong>The safety analysis included 815 patients, and the effectiveness analysis included 768 patients. Adverse reactionsthat occurred in 144 patients (17.67%) were mainly site-related events that occurred early in the dosing period. Seriousadverse reactions were dyspnea and anaphylactic reaction in one patient each, and both patients recovered. With regard toeffectiveness, compared with scores before the administration of SQ-HDM, nasal symptom scores decreased, depending on theadministration period, from 6 months to 3 years. Overall, 67.34% of the patients had improved quality of life after 6 months, and this improvement continued after 12 months. The proportion of patients with \"improved and slightly improved\" of overallimprovement exceeded 90% after 2 years. Treatment discontinuation because \"symptoms disappeared\" occurred in 24.42% of the patients at 3 years. Patients who discontinued 10,000 JAU (n = 39) had a sustained improvement in nasal symptomscores compared with baseline, even 1 year after discontinuing treatment.</p><p><strong>Conclusion: </strong>The real-world safety and effectiveness of 10,000 JAU SQ-HDM sublingual immunotherapy tablets were confirmed in Japanese patients with HDM AR. No new safety and effectiveness precautions were required.</p>","PeriodicalId":7646,"journal":{"name":"Allergy and asthma proceedings","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142611809","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-01DOI: 10.2500/aap.2024.45.240040
Yen-Chih Huang, Lisa Caldarone, Cherrie Sherman, Roger Deutsch, Jaeil Ahn, Joseph A Bellanti
<p><p><b>Background:</b> Adverse allergic reactions due to the administration of vaccines developed for the protection of coronavirus disease 2019 (COVID-19) have been reported since the initiation of the vaccination campaigns in December 15, 2020. Current analyses provided by the Centers for Disease Control and Prevention and the U.S. Food and Drug Administration in the United States have estimated the rates of anaphylactic reactions in 2.5 and 11.1 per million of messenger RNA (mRNA) 1273 and BNT162b2 vaccines administered, respectively. The mechanisms by which these mRNA vaccines induce adverse vaccine reactions have been the subject of conflicting reports. Although skin testing with excipient components found in mRNA-1273 and BNT162b2 vaccines, such as polyethylene glycol (PEG) and related vaccine lipid products, were originally recommended to identify potential predictive biomarkers of adverse allergic reactions, more recent evidence has suggested that routine skin testing with these vaccine excipients have poor predictability and do not correlate with susceptibility to vaccine injury. <b>Objective:</b> The goal of this proof-of-concept (POC) exploratory study was to investigate the role of leukocyte activation (LA) induced by lipid excipients found in mRNA COVID-19 vaccines in the pathogenesis of COVID-19 mRNA vaccine-associated adverse reactions by using an LA assay developed in our laboratory. <b>Results:</b> An LA assay was performed on blood samples obtained from 30 study subjects who were assigned to three study groups: group 1 consisted of 10 subjects who had received an mRNA COVID-19 vaccine and developed a serious vaccine adverse reaction; group 2 consisted of 10 subjects who had received a COVID-19 vaccine and developed a mild adverse reaction; and group 3 consisted of 10 subjects who had not received a COVID-19 vaccine and were asymptomatic. Five excipients were tested in each of the 10 subjects; hence, a potential of 50 reactions could be expressed in each of the three groups. In the subjects in group 1 who had shown clinically severe vaccine effects, 8 of 50 (16%) had severe LA index (LAI) responses (>144.83), 12 of 50 (24%) had moderate LAI responses (87.62 -144.82), and 30 of 50 (60%) had no reaction (0 - 87.61). In the subjects in group 2 who had shown clinically mild vaccine effects, 4 of 50 (8%) had severe LAI responses (>144.83), 9 of 50 (18%) had moderate LAI responses (87.62 -144.82), and 37 of 50 (74%) had no reaction. In the subjects in group 3 who had not received the vaccine and, therefore, had no clinical vaccine effects, 2 of 50 (4%) had severe LAI responses (>144.83), 10 of 50 (20%) had moderate LAI responses (87.62 -144.82), and 38 of 50 (76%) had no reaction LA index (LAI) responses. <b>Conclusion:</b> The results of this exploratory POC study suggest that the measurement of LA induced by PEG and other vaccine-related lipid excipients found in mRNA COVID-19 vaccines may provide a novel and useful predictive biom
{"title":"The role of leukocyte activation in suspected Non-IgE excipient-related COVID-19 vaccine reactions: An exploratory hypothesis-driven study of pathogenesis.","authors":"Yen-Chih Huang, Lisa Caldarone, Cherrie Sherman, Roger Deutsch, Jaeil Ahn, Joseph A Bellanti","doi":"10.2500/aap.2024.45.240040","DOIUrl":"10.2500/aap.2024.45.240040","url":null,"abstract":"<p><p><b>Background:</b> Adverse allergic reactions due to the administration of vaccines developed for the protection of coronavirus disease 2019 (COVID-19) have been reported since the initiation of the vaccination campaigns in December 15, 2020. Current analyses provided by the Centers for Disease Control and Prevention and the U.S. Food and Drug Administration in the United States have estimated the rates of anaphylactic reactions in 2.5 and 11.1 per million of messenger RNA (mRNA) 1273 and BNT162b2 vaccines administered, respectively. The mechanisms by which these mRNA vaccines induce adverse vaccine reactions have been the subject of conflicting reports. Although skin testing with excipient components found in mRNA-1273 and BNT162b2 vaccines, such as polyethylene glycol (PEG) and related vaccine lipid products, were originally recommended to identify potential predictive biomarkers of adverse allergic reactions, more recent evidence has suggested that routine skin testing with these vaccine excipients have poor predictability and do not correlate with susceptibility to vaccine injury. <b>Objective:</b> The goal of this proof-of-concept (POC) exploratory study was to investigate the role of leukocyte activation (LA) induced by lipid excipients found in mRNA COVID-19 vaccines in the pathogenesis of COVID-19 mRNA vaccine-associated adverse reactions by using an LA assay developed in our laboratory. <b>Results:</b> An LA assay was performed on blood samples obtained from 30 study subjects who were assigned to three study groups: group 1 consisted of 10 subjects who had received an mRNA COVID-19 vaccine and developed a serious vaccine adverse reaction; group 2 consisted of 10 subjects who had received a COVID-19 vaccine and developed a mild adverse reaction; and group 3 consisted of 10 subjects who had not received a COVID-19 vaccine and were asymptomatic. Five excipients were tested in each of the 10 subjects; hence, a potential of 50 reactions could be expressed in each of the three groups. In the subjects in group 1 who had shown clinically severe vaccine effects, 8 of 50 (16%) had severe LA index (LAI) responses (>144.83), 12 of 50 (24%) had moderate LAI responses (87.62 -144.82), and 30 of 50 (60%) had no reaction (0 - 87.61). In the subjects in group 2 who had shown clinically mild vaccine effects, 4 of 50 (8%) had severe LAI responses (>144.83), 9 of 50 (18%) had moderate LAI responses (87.62 -144.82), and 37 of 50 (74%) had no reaction. In the subjects in group 3 who had not received the vaccine and, therefore, had no clinical vaccine effects, 2 of 50 (4%) had severe LAI responses (>144.83), 10 of 50 (20%) had moderate LAI responses (87.62 -144.82), and 38 of 50 (76%) had no reaction LA index (LAI) responses. <b>Conclusion:</b> The results of this exploratory POC study suggest that the measurement of LA induced by PEG and other vaccine-related lipid excipients found in mRNA COVID-19 vaccines may provide a novel and useful predictive biom","PeriodicalId":7646,"journal":{"name":"Allergy and asthma proceedings","volume":"45 6","pages":"438-446"},"PeriodicalIF":2.6,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11572939/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142612108","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-01DOI: 10.2500/aap.2024.45.240059
Marcus S Shaker
Patients and families living with food allergy may experience significant burdens, including social isolation, impaired quality of life, and anxiety. Allergists/immunologists play a critical role in educating families living with food allergies about risk, particularly with regard to the rarity of fatal food allergy. Appropriate risk framing can greatly decrease the fear-based burden of disease. In 2024, an increasing complex fabric of food allergy treatments has emerged that includes oral immunotherapy (OIT), sublingual immunotherapy (SLIT), and omalizumab, with the promise of additional treatments, including epicutaneous immunotherapy and oral mucosal immunotherapy in the near future. Younger children may be most likely to benefit from OIT and SLIT, with some evidence that suggests the possibility of an immunomodulatory effect. Omalizumab, approved in 2024 for use in conjunction with strict avoidance, increases the threshold of reactivity before a moderate-to-severe reaction for many, but not all, patients. There is no evidence to date that omalizumab has an immunomodulatory effect, and young children treated with omalizumab monotherapy may bear a lost opportunity cost from possible immunomodulation would they have been treated with OIT or SLIT instead; however, within a shared decision-making paradigm, beyond label use of omalizumab may include treatment with OIT or SLIT. Fortunately, the co-evolution of shared decision-making with modern food allergy treatments will facilitate the critical preference-sensitive care that must be characteristic of all decisions surrounding active food allergy management.
{"title":"The use of biologics in food allergy management.","authors":"Marcus S Shaker","doi":"10.2500/aap.2024.45.240059","DOIUrl":"https://doi.org/10.2500/aap.2024.45.240059","url":null,"abstract":"<p><p>Patients and families living with food allergy may experience significant burdens, including social isolation, impaired quality of life, and anxiety. Allergists/immunologists play a critical role in educating families living with food allergies about risk, particularly with regard to the rarity of fatal food allergy. Appropriate risk framing can greatly decrease the fear-based burden of disease. In 2024, an increasing complex fabric of food allergy treatments has emerged that includes oral immunotherapy (OIT), sublingual immunotherapy (SLIT), and omalizumab, with the promise of additional treatments, including epicutaneous immunotherapy and oral mucosal immunotherapy in the near future. Younger children may be most likely to benefit from OIT and SLIT, with some evidence that suggests the possibility of an immunomodulatory effect. Omalizumab, approved in 2024 for use in conjunction with strict avoidance, increases the threshold of reactivity before a moderate-to-severe reaction for many, but not all, patients. There is no evidence to date that omalizumab has an immunomodulatory effect, and young children treated with omalizumab monotherapy may bear a lost opportunity cost from possible immunomodulation would they have been treated with OIT or SLIT instead; however, within a shared decision-making paradigm, beyond label use of omalizumab may include treatment with OIT or SLIT. Fortunately, the co-evolution of shared decision-making with modern food allergy treatments will facilitate the critical preference-sensitive care that must be characteristic of all decisions surrounding active food allergy management.</p>","PeriodicalId":7646,"journal":{"name":"Allergy and asthma proceedings","volume":"45 6","pages":"409-413"},"PeriodicalIF":2.6,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142612102","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-01DOI: 10.2500/aap.2024.45.240086
Elen Deng, Timothy J Craig, Dinh V Nguyen, Taha Al-Shaikhly
Background: Sulfonamides are associated with severe cutaneous adverse reactions (SCARs). Coronavirus disease 2019 (COVID-19) triggers an immune response, which may increase the likelihood of developing a hypersensitivity reaction. Objectives: We sought to explore the impact of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection on the probability of developing SCARs and/or erythema multiforme (EM) reactions to sulfonamides. Methods: In the propensity score-matched cohort study by using the de-identified TriNetX Research data base, patients who had an exposure to antibiotic or non-antibiotic sulfonamides between March 1, 2020, and January 1, 2023, were divided into two groups based on the presence or absence of a previous COVID-19 infection within 6 months of starting the sulfonamide agent. The outcomes studied were the 30-day risk of developing SCARs or EM (Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, or EM) within 3 months of sulfonamide exposure. Cohorts were matched based on baseline demographics; malignant lymphoid neoplasms; human immunodeficiency virus; systemic lupus erythematosus; bone marrow transplantation; diabetes; psoriasis; seizures; gout; solid organ or stem cell transplantation; COVID-19 vaccination; and exposure to risk medications, including allopurinol, levetiracetam, carbamazepine, lamotrigine, oxcarbazepine, phenytoin, phenobarbital, abacavir, nevirapine, piroxicam, tenoxicam, or mexiletine. Results: When comparing 345,119 patients on sulfonamides and with previous COVID-19 to an equal number of sulfonamides users without a previous COVID-19, patients with COVID-19 had a lower risk of developing any form of SCARs (relative risk 0.39 [95% confidence interval, 0.26, 0.58]; p < 0.001). Conclusion: Previous SARS-CoV-2 infection seems to be associated with a lower probability of developing SCARs or EM among patients using sulfonamides.
{"title":"COVID-19 and severe cutaneous allergic reactions to sulfonamides.","authors":"Elen Deng, Timothy J Craig, Dinh V Nguyen, Taha Al-Shaikhly","doi":"10.2500/aap.2024.45.240086","DOIUrl":"10.2500/aap.2024.45.240086","url":null,"abstract":"<p><p><b>Background:</b> Sulfonamides are associated with severe cutaneous adverse reactions (SCARs). Coronavirus disease 2019 (COVID-19) triggers an immune response, which may increase the likelihood of developing a hypersensitivity reaction. <b>Objectives:</b> We sought to explore the impact of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection on the probability of developing SCARs and/or erythema multiforme (EM) reactions to sulfonamides. <b>Methods:</b> In the propensity score-matched cohort study by using the de-identified TriNetX Research data base, patients who had an exposure to antibiotic or non-antibiotic sulfonamides between March 1, 2020, and January 1, 2023, were divided into two groups based on the presence or absence of a previous COVID-19 infection within 6 months of starting the sulfonamide agent. The outcomes studied were the 30-day risk of developing SCARs or EM (Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, or EM) within 3 months of sulfonamide exposure. Cohorts were matched based on baseline demographics; malignant lymphoid neoplasms; human immunodeficiency virus; systemic lupus erythematosus; bone marrow transplantation; diabetes; psoriasis; seizures; gout; solid organ or stem cell transplantation; COVID-19 vaccination; and exposure to risk medications, including allopurinol, levetiracetam, carbamazepine, lamotrigine, oxcarbazepine, phenytoin, phenobarbital, abacavir, nevirapine, piroxicam, tenoxicam, or mexiletine. <b>Results:</b> When comparing 345,119 patients on sulfonamides and with previous COVID-19 to an equal number of sulfonamides users without a previous COVID-19, patients with COVID-19 had a lower risk of developing any form of SCARs (relative risk 0.39 [95% confidence interval, 0.26, 0.58]; p < 0.001). <b>Conclusion:</b> Previous SARS-CoV-2 infection seems to be associated with a lower probability of developing SCARs or EM among patients using sulfonamides.</p>","PeriodicalId":7646,"journal":{"name":"Allergy and asthma proceedings","volume":"45 6","pages":"e93-e100"},"PeriodicalIF":2.6,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11572944/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142612027","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-01DOI: 10.2500/aap.2024.45.240077
Vishaka R Hatcher, Karla E Adams
Knowledge of the military regulations is key to guiding medical evaluations for applicants and service members. Military and civilian allergy consultants are often called on for their expertise to provide guidance with regard to the allergic conditions that may be potentially disqualifying from service per the published regulations for accession and retention. This review focuses on the role of the allergy consultant in military accession, retention, and deployments. To better understand and attempt to define the role of the allergy consultant in the process of medical evaluation for military applicants and for active duty service members, in the context of the ongoing national recruitment and force sustainment crisis, it is imperative to comprehend the intricacies of military accession and retention guidelines. Military medical standards guidelines are easy to access and should be used when evaluating applicants or active duty service members with allergic conditions. Medical documentation that aligns with military guidelines can help our patients streamline accession, retention, and waiver requests. The objective of this review is to provide a framework for how to address allergic concerns in the context of military service and apply accession and retention standards as indicated for patients who present with common allergic diagnoses.
{"title":"Military accession, retention, and deployment: Defining the role of the allergy consultant.","authors":"Vishaka R Hatcher, Karla E Adams","doi":"10.2500/aap.2024.45.240077","DOIUrl":"10.2500/aap.2024.45.240077","url":null,"abstract":"<p><p>Knowledge of the military regulations is key to guiding medical evaluations for applicants and service members. Military and civilian allergy consultants are often called on for their expertise to provide guidance with regard to the allergic conditions that may be potentially disqualifying from service per the published regulations for accession and retention. This review focuses on the role of the allergy consultant in military accession, retention, and deployments. To better understand and attempt to define the role of the allergy consultant in the process of medical evaluation for military applicants and for active duty service members, in the context of the ongoing national recruitment and force sustainment crisis, it is imperative to comprehend the intricacies of military accession and retention guidelines. Military medical standards guidelines are easy to access and should be used when evaluating applicants or active duty service members with allergic conditions. Medical documentation that aligns with military guidelines can help our patients streamline accession, retention, and waiver requests. The objective of this review is to provide a framework for how to address allergic concerns in the context of military service and apply accession and retention standards as indicated for patients who present with common allergic diagnoses.</p>","PeriodicalId":7646,"journal":{"name":"Allergy and asthma proceedings","volume":"45 6","pages":"404-408"},"PeriodicalIF":2.6,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11572943/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142612092","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: Asthma is the most prevalent chronic respiratory disease in children, and gastroesophageal reflux disease (GERD) is one of its extraesophageal complications of asthma. Both conditions are commonly observed in pediatric outpatient clinics, but the causality between them in children is still debated. Therefore, we conducted a systematic review and meta-analysis to evaluate the bidirectional association between asthma and GERD in children. Methods: We systematically reviewed original studies published from January 2000 to February 2024 by searching the data bases. We also performed manual retrieval and screening to identify studies that met the inclusion criteria. The quality of the final included studies was evaluated by using the Newcastle-Ottawa Scale, and outcome measures were extracted. Results: We identified nine eligible studies, which included 304,399 children of different ages from seven countries. Overall, the risk of developing GERD in children with asthma (odds ratio [OR] 2.16 [95% confidence interval [CI], 1.6-2.91) was higher than the risk of developing asthma in children with GERD (OR 1.55 [95% CI, 1.32-1.82]). Conclusion: Based on the available studies, it can be concluded that asthma and GERD are mutually aggravating factors in children, presenting a bidirectional association. However, the risk of developing GERD in children with asthma is higher to some extent. More large-scale and high-quality prospective cohort studies are needed in the future to provide richer evidence and more research opportunities.
{"title":"A systematic review and meta-analysis exploring the bidirectional association between asthma and gastroesophageal reflux disease in children.","authors":"KaiWen Zheng, Xiang Wang, LinYan Tang, Ling Chen, YuLing Zhao, Xing Chen","doi":"10.2500/aap.2024.45.240085","DOIUrl":"10.2500/aap.2024.45.240085","url":null,"abstract":"<p><p><b>Background:</b> Asthma is the most prevalent chronic respiratory disease in children, and gastroesophageal reflux disease (GERD) is one of its extraesophageal complications of asthma. Both conditions are commonly observed in pediatric outpatient clinics, but the causality between them in children is still debated. Therefore, we conducted a systematic review and meta-analysis to evaluate the bidirectional association between asthma and GERD in children. <b>Methods:</b> We systematically reviewed original studies published from January 2000 to February 2024 by searching the data bases. We also performed manual retrieval and screening to identify studies that met the inclusion criteria. The quality of the final included studies was evaluated by using the Newcastle-Ottawa Scale, and outcome measures were extracted. <b>Results:</b> We identified nine eligible studies, which included 304,399 children of different ages from seven countries. Overall, the risk of developing GERD in children with asthma (odds ratio [OR] 2.16 [95% confidence interval [CI], 1.6-2.91) was higher than the risk of developing asthma in children with GERD (OR 1.55 [95% CI, 1.32-1.82]). <b>Conclusion:</b> Based on the available studies, it can be concluded that asthma and GERD are mutually aggravating factors in children, presenting a bidirectional association. However, the risk of developing GERD in children with asthma is higher to some extent. More large-scale and high-quality prospective cohort studies are needed in the future to provide richer evidence and more research opportunities.</p>","PeriodicalId":7646,"journal":{"name":"Allergy and asthma proceedings","volume":"45 6","pages":"e101-e110"},"PeriodicalIF":2.6,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142611995","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}